Alembic Pharma Gets US FDA Nod for Travoprost Eye Solution

Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for travoprost ophthalmic solution USP, 0.004%. The product is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

According to IQVIA data, the approved product has an estimated market size of approximately US $61 million for the 12-month period ending September 2025. The drug has been approved as therapeutically equivalent to the reference listed drug (RLD), Travatan Z ophthalmic solution, 0.004%, marketed by Sandoz Inc. This approval enables Alembic Pharmaceuticals to launch a generic travoprost eye drop in the US generics market, subject to regulatory and commercial considerations.

Travoprost ophthalmic solution is a prostaglandin analogue used to manage intraocular pressure by increasing the outflow of aqueous humor from the eye. Elevated intraocular pressure is a major risk factor for glaucoma, a condition that can lead to irreversible vision loss if not treated effectively. Ophthalmic drugs remain a key segment within the US pharmaceutical market, supported by a growing aging population and rising prevalence of chronic eye disorders.

With this approval, Alembic’s ANDA filings with the US FDA have reached 232, including 212 final approvals and 20 tentative approvals. The latest approval strengthens the company’s ophthalmic generics portfolio and expands its presence in regulated markets.

Alembic Pharmaceuticals, founded in 1907, is a vertically integrated pharmaceutical company engaged in the development, manufacturing, and marketing of generic medicines. The company operates multiple US FDA–approved manufacturing facilities. In India, Alembic has a strong position in the branded generics market across major therapeutic areas.

Also Read: Novartis Strengthens Indian Operations With Biggest R&D Hub Globally

The US FDA approval supports Alembic’s strategy of expanding its product pipeline, increasing generic drug launches, and strengthening its footprint in complex and specialty dosage forms across global markets.